Couples in the United States and the other industrialized countries have between a 15–20% likelihood of failing to conceive children without some medical intervention. Male Factor Infertility is directly responsible for approximately one-third and a contributing factor in over half of failed conceptions. In order to plan the most appropriate medical interventions, the status of the male semen sample must be accurately determined. According to the World Health Organization criteria for male fertility, the primary factors governing male fertility are semen volume, and sperm cell density, motility, forward progression, and morphology. These criteria are not independent. For example, a semen sample with a high-density of forwardly progressing sperm also has high motility and an acceptably low rate of morphological defects. Therefore, by correctly measuring the density of forwardly progressing sperm cells within a semen sample and comparing these results to international medical standards, Male Factor Infertility can be ruled-out as a cause for failed conception, or identified and treated according to current medical practices.
Currently, nearly all semen samples are analyzed in the laboratory setting at major hospitals, medical centers, and fertility clinics secondary to a physician referral. A trained technician performs most semen analysis. The sample is observed under a microscope and several aspects of the sperm cell composition are quantified, such as density, percent motility, percent morphologically abnormal, and forward progression. At this time, a single over-the-counter product that performs semen cell count is also available in the UK and US.
Analysis of semen samples for couples who are failing to conceive is currently limited by several factors. Many couples are reluctant to seek medical advice for fertility problems until difficulties and stressors have persisted for long periods of time. Once medical advice is sought, men are particularly unwilling to seek semen analysis due to embarrassment and lack of privacy. The need for trained personnel and laboratory testing is partly responsible for the high cost of fertility management. Low cost and private alternatives to semen analysis, such as the in-home cell count assay available from the UK, fail to discriminate between sperm cells in the semen sample and other cell types and fail to analyze any motility characteristics of the sperm cells within the sample. It would thus be desirable to provide an in-home method and device for assaying sperm count and motility that substantially overcomes these limitations.